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Solid preparation of ranitidine hydrochloride/bismuth potassium citrate medicinal composition

A technology of ranitidine hydrochloride and potassium bismuth citrate, which is applied in the field of medicine, can solve the problems of low bioavailability, poor stability of ranitidine hydrochloride, peaks and troughs of release, etc., and achieves high bioavailability and reduces drugs. Side effects, release smooth and long-lasting effects

Inactive Publication Date: 2010-10-20
郝志艳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Ranitidine hydrochloride / bismuth potassium citrate pharmaceutical composition solid preparation has no related patent reports in China. The domestically produced varieties include compound ranitidine tablets, compound ranitidine capsules and compound ranitidine granules. However, these varieties are all produced by general production techniques, resulting in poor long-term storage stability of ranitidine hydrochloride, and the phenomenon of peaks and valleys in the release, resulting in low bioavailability

Method used

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  • Solid preparation of ranitidine hydrochloride/bismuth potassium citrate medicinal composition
  • Solid preparation of ranitidine hydrochloride/bismuth potassium citrate medicinal composition
  • Solid preparation of ranitidine hydrochloride/bismuth potassium citrate medicinal composition

Examples

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Embodiment 1

[0070] The preparation prescription (1000) of embodiment 1 ranitidine hydrochloride / bismuth potassium citrate tablet

[0071] Ranitidine Hydrochloride 100g

[0072] Bismuth Potassium Citrate 110g

[0073] Chitosan 400g

[0074] Sodium Alginate 160g

[0075] Lactose 100g

[0076] 150g pregelatinized starch

[0077] Carboxymethyl Starch Sodium 60g

[0078] Povidone K30 15g

[0079] Talc powder 35g

[0080] Magnesium Stearate 10g

[0081] Preparation Process

[0082] (1) 100g ranitidine hydrochloride, 110g bismuth potassium citrate, 400g chitosan, and 160g sodium alginate were dissolved in 2000ml of purified water to obtain an aqueous phase;

[0083] (2) Mix 1000ml peanut oil and 4000ml chloroform evenly to obtain an oil phase;

[0084] (3) Slowly drip the water phase obtained above into the oil phase under stirring conditions, stir and emulsify for 10 minutes after dripping, then add 50g of sodium lauryl sulfate to make the gel completely, then add 500ml of n-hexane an...

Embodiment 2

[0089] The preparation prescription (1000) of embodiment 2 ranitidine hydrochloride / bismuth potassium citrate capsules

[0090] Ranitidine Hydrochloride 150g

[0091] Bismuth Potassium Citrate 110g

[0092] Chitosan 300g

[0093] Sodium Alginate 80g

[0094] Microcrystalline Cellulose 100g

[0095] Low-substituted hydroxypropyl cellulose 65g

[0096] Sodium Carboxymethyl Cellulose 3g

[0097] Talc powder 35g

[0098] Preparation Process

[0099] (1) 150g ranitidine hydrochloride, 110g bismuth potassium citrate, 300g chitosan, and 80g sodium alginate were dissolved in 2000ml of purified water to obtain an aqueous phase;

[0100] (2) Mix 1000ml peanut oil and 4000ml chloroform evenly to obtain an oil phase;

[0101] (3) Slowly drip the water phase obtained above into the oil phase under stirring conditions, stir and emulsify for 30min after dripping, then add 40g of sodium lauryl sulfate to make the gel completely, then add 500ml of n-hexane and 500ml of water , the two...

Embodiment 3

[0106] The preparation prescription (1000 bags) of embodiment 3 ranitidine hydrochloride / bismuth potassium citrate granules

[0107] Ranitidine Hydrochloride 100g

[0108] Bismuth Potassium Citrate 110g

[0109] Chitosan 500g

[0110] Sodium Alginate 240g

[0111] Sucrose 280g

[0112] Aspartame 30g

[0113] Mannitol 70g

[0114] Povidone K30 20g

[0115] Preparation Process

[0116] (1) 100g ranitidine hydrochloride, 110g bismuth potassium citrate, 500g chitosan, and 240g sodium alginate were dissolved in 2500ml of purified water to obtain an aqueous phase;

[0117] (2) Mix 1000ml peanut oil and 4000ml chloroform evenly to obtain an oil phase;

[0118] (3) Slowly drip the water phase obtained above into the oil phase under stirring conditions, stir and emulsify for 20min after dripping, then add 50g of sodium lauryl sulfate to make the gel completely, then add 500ml of n-hexane and 500ml of water , the two phases are separated, and the microcapsules sink in the water...

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Abstract

The invention relates to the solid preparation of a ranitidine hydrochloride / bismuth potassium citrate medicinal composition, which is prepared by mixing ranitidine hydrochloride / bismuth potassium citrate medicinal composition microcapsules and other pharmaceutical adjuvant required by the preparation of the solid preparation, wherein the ranitidine hydrochloride / bismuth potassium citrate medicinal composition microcapsules are prepared from ranitidine hydrochloride, bismuth potassium citrate, chitosan and sodium alginate. Compared with the prior art, the preparation of the invention has the characteristics of greatly improved stability and bioavailability, and stable and persistent release.

Description

technical field [0001] The invention relates to a solid preparation of ranitidine hydrochloride / bismuth potassium citrate pharmaceutical composition and a preparation method thereof. The preparation of solid preparation by mixing pharmaceutical auxiliary materials belongs to the technical field of medicine. Background technique [0002] Ranitidine is a reversible and competitive histamine H2 receptor antagonist, it will not reduce the serum calcium ion concentration in hypercalcemia, and it is not an anticholinergic drug. Clinical studies have shown that ranitidine can inhibit the secretion of basal gastric acid and the secretion of gastric acid stimulated by diethylpyrazole and pentagastrin, without affecting the secretion of pepsin and the secretion of intrinsic factor stimulated by pentagastrin , had little effect on fasting and postprandial serum gastrin levels. Bismuth potassium citrate can disintegrate rapidly in the stomach. Under the action of gastric acid, the wat...

Claims

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Application Information

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IPC IPC(8): A61K31/341A61K31/194A61K9/50A61P1/04A61P31/04
Inventor 郝志艳
Owner 郝志艳
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